A functional observational battery in non-human primates for regulatory-required neurobehavioral assessments

IntroductionThe objective of this study was to establish a functional observational battery that provided a basic neurological and behavioral assessment fully compliant with requisite governmental regulatory guidelines.MethodsAccredited Laboratory Animal Technicians (ALAT) were trained to conduct neurobehavioral assessments in rhesus monkeys prior to and following vehicle (po), 3.2 mg/kg amphetamine (po) and 5.6 mg/kg ketamine (im) administrations. The observational battery was designed to be compliant with the goals of standard veterinary neurological examinations and federal and international regulatory guidelines related to neurotoxicity safety assessments.ResultsA complete neurobehavioral assessment that: 1) was safe for both non-human primate and the animal technicians conducting the assessments, 2) that examined both autonomic and central nervous system functions and, 3) that easily discriminated between the hallmark behavioral pharmacology characterizing respective psychostimulant, dissociative anesthetic, and “normal” (vehicle).DiscussionWe believe that these procedures provide safe, effective methodology reflecting contemporary industry's preferred practices for measuring such basic neurobehavioral functioning under the ICH, EPA, and FDA guidelines, and which is amenable to routine use within the context of efficacy, safety pharmacology, and toxicological investigations.